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United States · US · US:59630-266_64c35e73-1daa-4a82-a3c2-a737dec6eeae
Fetroja
Orange BookUNIISPLATC J01DI
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerShionogi Inc.
CountryUS (United States)
ATC codeJ01DI
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11596302661010 VIAL, SINGLE-USE in 1 CARTON (59630-266-10) / 10 mL in 1 VIAL, SINGLE-USE (59630-266-01)
Annotations
UNII (FDA Substance ID)
TTP8LBP45D
CEFIDEROCOL SULFATE TOSYLATE
RxCUI 2265863
Orange Book
N209445
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TTP8LBP45D",
"rxcui": "2265863",
"inchikey": "QNMVZYPDWLKAJC-RXVBEKIDSA-N",
"display_name": "CEFIDEROCOL SULFATE TOSYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"75c0c785-38e0-4049-a6fb-b77581f5b35c": {
"match": "brand_token",
"title": "FETROJA (CEFIDEROCOL SULFATE TOSYLATE) INJECTION, POWDER, FOR SOLUTION [SHIONOGI INC.]",
"spl_version": "11",
"published_date": "2026-04-30"
}
},
"productid": "59630-266_64c35e73-1daa-4a82-a3c2-a737dec6eeae",
"productndc": "59630-266",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "209445",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1GM BASE/VIAL",
"product_no": "001",
"approval_date": "Nov 14, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEFIDEROCOL SULFATE TOSYLATE",
"proprietary_name": "Fetroja",
"active_ingred_unit": "g/10mL",
"application_number": "NDA209445",
"marketing_category": "NDA",
"nonproprietary_name": "Cefiderocol sulfate tosylate",
"start_marketing_date": "20200131",
"active_numerator_strength": "1"
}Access this data programmatically
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